RecruitingNCT07167251

Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids

Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study

Sponsor

University Hospital, Basel, Switzerland

Enrollment

63 participants

Start Date

Aug 25, 2025

Study Type

OBSERVATIONAL

Conditions

Cancer Immune-Mediated Hepatitis Immune-related Adverse Events

Summary

This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors. It aims to determine whether of 0.5-1miligram per kilogram bodyweight prednisolone is sufficient to manage immune-related hepatitis without the need for dose escalation or additional immunosuppressive therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Low-dose corticosteroids for immune-related hepatitis grade 2 and a drug called Low-dose corticosteroids for immune-related hepatitis grade 3 for people with cancer, immune-mediated hepatitis, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow-dose corticosteroids for immune-related hepatitis grade 3

Prednisolone 0.5-1 mg/kg orally for grade 3 IR-hepatitis; adjusted based on liver function; treatment per local standard of care.

DRUGLow-dose corticosteroids for immune-related hepatitis grade 2

Hold immunotherapy and reassess liver function at the treating physician's discretion. If liver function tests persistently worsen or continue to rise, consider administering prednisolone at 0.5 mg/kg body weight